Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT03477266
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2018-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C062720', 'term': 'mosapride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Color coded active tablets backed in red while identical dummy tablets coded in blue,both tablets are physically identical and usually no anticipated noticed side effects from mosapride'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-12', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of first flatus', 'timeFrame': '96 hours postoperative', 'description': 'Clinical'}], 'secondaryOutcomes': [{'measure': 'Paralytic ileus incidence and its severity', 'timeFrame': '7days', 'description': 'Clinical'}, {'measure': 'Toleration of fluids and solids intake', 'timeFrame': '2 weeks postoperative', 'description': 'Clinical'}, {'measure': 'Incidence of intraoperative and postoperative nausea and vomiting', 'timeFrame': 'Intraoperative and 2 weeks postoperative', 'description': 'Clinical'}, {'measure': 'First defecation', 'timeFrame': '2 weeks postoperative', 'description': 'Clinical'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative ileus', 'mosapride', 'mouth dissolving tablets', 'Intraoperative vomiting'], 'conditions': ['Prevention of Postoperative Ileus']}, 'descriptionModule': {'briefSummary': 'Giving women one day before and immediately after cesarean section a mouthly dissolving mosapride tablets 2every every 8 hours for maximum of 5 days ,or getting recovered gastrointestinal functions And assess preoperative gastrointestinal functions', 'detailedDescription': "Uncomplicated post cesarean women one day before and immediately after elective cesarean receive 2 mouthly dissolving mosapride tablets every 8 hours maximum for 5 days and clinical care giver follow the woman's gastrointestinal functions, including intraoperative and postoperative nausea vomiting, passing flatus, hearing intestinal sounds, passing stools, occurring of paralytic ileus, length of the hospital stay"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'After cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all women undergoing elective cesarean section\n\nExclusion Criteria:\n\n* prior abdominal surgery, abdominal adhesion, chronic constipation, allergy to mosapride'}, 'identificationModule': {'nctId': 'NCT03477266', 'briefTitle': 'Mouth Dissolving Mosapride Tables Enhance Post Cesarean Gut Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Effectiveness of Mouth Dissolving Mosapride Tablets on Enhancing Gut Recovery After Cesarean Section: Randomized Double-blind, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'Ashrafnassif2002@yahoo.com'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mouth dissolving mosapride', 'description': 'Fluxopride 5mg of Macryrl egypt 2 tablets one day before and immediately after elective cesarean section every 8hour for maximum of 5 days', 'interventionNames': ['Drug: Mosapride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo mouth dissolving tablets', 'description': 'Dummy identical tablets taken in the same way', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Mosapride', 'type': 'DRUG', 'otherNames': ['Fluxopride'], 'description': 'Intake mouthly dissolving mosapride tablets in immediate post cesarean section', 'armGroupLabels': ['Mouth dissolving mosapride']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Dummy identical tablets to mouthly dissolving mosapride tablets', 'armGroupLabels': ['Placebo mouth dissolving tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banhā', 'state': 'Elqalopia', 'country': 'Egypt', 'facility': 'Ashraf nassif Elmantwe', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Ashraf N Elmantwe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When data became available and for ever', 'ipdSharing': 'YES', 'description': 'Once data collected and analyzed and published', 'accessCriteria': 'Any'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'ashraf nassif mahmoud elmantwe,MD', 'investigatorAffiliation': 'Benha University'}}}}